As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance focuses on promotional materials related to biosimilar products, but also addresses issues that may arise in the promotion of biological reference products for which biosimilar competitors have been approved. In conjunction with the issuance of the draft guidance, FDA also responded to a 2018 citizen petition requesting clarification regarding issues surrounding the promotion of reference biologic products and biosimilar products. In that petition response and in the Federal Register Notice announcing the draft guidance, FDA invited public comment on these issues and on promotional considerations related to interchangeable biosimilars, which are not addressed in the draft guidance.
To ensure that promotional materials for biosimilar products and their reference products comply with the Federal Food, Drug and Cosmetic Act (FDCA) and FDA’s implementing regulations, the draft guidance advises, among other things, that:
- Promotional labeling and advertising should correctly and specifically identify the product(s) to which information applies (e.g., the reference product, the biosimilar product, a non-U.S.-licensed comparator biological product) in each instance where the promotional materials address a product or products.
- Because of the statutory standards for licensure of a biosimilar, FDA will likely consider promotional materials to be false or misleading if they “create an impression that there are clinically meaningful differences between the reference product and its biosimilar” or “that a biosimilar is not highly similar to its reference product.”
- Promotional materials should not represent or suggest that a finding of biosimilarity means FDA determined that the reference product and biosimilar product are “identical.” Similarly, promotional materials for a reference product should not imply that a biosimilar product is less safe or effective than the reference product because the biosimilar is not “identical” to the reference product or because the biosimilar has not been licensed as interchangeable.
- Promotional materials may address data and information used to support a demonstration of biosimilarity and which are not included in the biosimilar product’s FDA-approved labeling. However, it must be done in a way that is consistent with the FDA-approved labeling, truthful, and non-misleading, as provided for in FDA’s “consistent with the FDA-required labeling” guidance.
- Where a biosimilar product’s FDA-approved labeling incorporates data and information from the reference product’s FDA-approved labeling, the promotional materials for the biosimilar product should refer to its labeling rather than the reference product labeling.
The draft guidance explains that a “fact-specific” analysis is necessary for FDA to decide whether a promotional presentation is truthful and non-misleading, and the agency considers such factors as “how the information is presented, the type and quality of the data relied on to support the presentation, and contextual and disclosure considerations.”
The draft guidance specifically addresses risks associated with comparative claims, including presentations of data involving a biosimilar and its reference product, and discussion of differences that are not clinically meaningful. FDA also reminds companies that even factually accurate information can give a false or misleading impression in a comparative context. As an example, the draft guidance states that it would be misleading for promotional materials to compare the number of indications for a reference product and a biosimilar product approved for a fewer number of indications in a manner that creates a net impression that the biosimilar product is less safe or effective on that basis.
In a joint statement published the same day, FDA and the Federal Trade Commission (FTC) pledged to work together to:
- coordinate to promote greater competition in biologic markets,
- deter behavior that impedes access to samples needed for the development of biologics, including biosimilars, and
- take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities.
The FTC also said it will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.
FDA announced an opportunity for the public to discuss the agencies’ collaborative efforts at a workshop on a competitive marketplace for biosimilars, which will take place at FDA’s White Oak Campus in Maryland on March 9, 2020.
Comments on the draft guidance will be accepted until April 6. Please reach out to the Hogan Lovells attorney with you whom you regularly work if you may wish to submit a comment on the draft guidance, or if you have any questions about promotional labeling and advertising considerations more generally.
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